Infectious Diseases News Alerts

• Alert FDA Issues Class l Recall of Three Blood Test Analyzers The agency alerted hospitals, labs, and other providers after recurring complaints of inaccurate platelet counts with three Beckman Coulter models. More than 2000 labs in the US may be affected.
  News Alerts, May 2019
• Alert FDA Clears First Zika Blood Test for Routine Use The ZIKV Detect 2.0 IgM Capture ELISA had previously been authorized only for emergency use under the FDA's emergency use authorization authority.
  FDA Approvals, May 2019
• Alert FDA Clears Assays for Extragenital Chlamydia/Gonorrhea Testing The Aptima Combo 2 Assay and the Xpert CT/NG are the first tests cleared for diagnostic testing for Chlamydia and gonorrhea via throat and rectal samples.
  FDA Approvals, May 2019
• Alert EU Panel Backs Market Withdrawal of Fenspiride Due to Heart Risk The European Medicines Agency's Pharmacovigilance Risk Assessment Committee recommended revoking marketing authorizations for fenspiride medicines, preventing them from being marketed in the EU.
  News Alerts, May 2019
• Alert FDA Approves First Vaccine for Dengue, With Restrictions Dengvaxia is for the prevention of dengue disease caused by all dengue virus serotypes in people aged 9 to 16 years who have previously had laboratory-confirmed dengue infection and who live in endemic areas.
  FDA Approvals, May 2019
• Alert FDA Approves Two-Drug Combo Mavyret for HCV in Adolescents The FDA approved glecaprevir and pibrentasvir (Mavyret, AbbVie) tablets for the treatment of all six hepatitis C virus (HCV) genotypes in children ages 12 to 17 years.
  FDA Approvals, April 2019
• Alert EU Panel Backs Dolutegravir/Lamivudine Combo Pill for HIV Dovato contains 50 mg dolutegravir and 300 mg lamivudine and would be the first once-daily, single-pill, completed 2-drug regimen for treatment of HIV in Europe.
  International Approvals, April 2019
• Alert Duodenoscope Contamination Rates Still Lethally High: FDA New data show 'high-concern' bacteria on 5.4% of properly reprocessed scopes; FDA reports three deaths in 2018 related to contaminated duodenoscopes.
  News Alerts, April 2019
• Alert FDA Clears New Drug-Sparing Option for HIV Infection The dolutegravir and lamivudine combination (Dovato) is the first once-daily, single-tablet, two-drug regimen for adults with treatment-naive HIV infection.
  Medscape Medical News, April 2019
• Alert FDA Warns Lab Against Marketing Tests Linking Genes, Drug Reaction Inova Genomics is cited for illegally marketing MediMap genetic tests that claim to predict a patient's response to antidepressants and other medications.
  News Alerts, April 2019
• Alert FDA OKs Certolizumab for Nonradiographic Axial Spondyloarthritis Certolizumab is the first FDA-approved treatment for this type of inflammatory arthritis and fulfills an unmet need for these patients, the FDA says.
  FDA Approvals, March 2019
• Alert FDA OKs Triclabendazole for Tropical Disease Fascioliasis Fascioliasis (liver fluke infestation) is a waterborne and foodborne neglected tropical disease affecting an estimated 2.4 million people worldwide, with an additional 180 million at risk.
  FDA Approvals, February 2019
• Alert FDA OKs First Targeted Therapy for Rare Blood Clotting Disorder Caplacizumab (Cablivi) injection is indicated in combination with plasma exchange and immunosuppressive therapy for adults with acquired thrombotic thrombocytopenic purpura (aTTP).
  FDA Approvals, February 2019
• Alert Abuse-Deterrent OxyContin Tied to Spike in Hepatitis C The introduction of abuse-deterrent OxyContin may be a factor in the sharp rise in hepatitis C infections in the United States because drug abusers switched to injectable heroin, research suggests.
  News Alerts, February 2019
• Alert FDA Clears First Diagnostic Test for Mycoplasma genitalium The Aptima nucleic acid amplification test detects Mycoplasma genitalium in urine, urethral, penile meatal, endocervical, and vaginal swab samples collected in a clinical setting.
  News Alerts, January 2019
• Alert Sanofi's Pediatric Hexavalent Vaccine Approved by U.S. FDA The U.S. Food and Drug Administration approved Sanofi's new pediatric vaccine immunizing children against six diseases, the French pharmaceutical lab said on Wednesday.
  Reuters Health Information, December 2018
• Alert Serious Infections From Unapproved Stem-Cell Treatments Identified in Multiple States Unapproved use of stem cells caused bloodstream and joint infections.
  News Alerts, December 2018
• Alert FDA Warns Genetech Over Unapproved Stem-Cell Products Twelve patients who received Genetech's unapproved products subsequently became ill from blood infections and other infections caused by a number of bacteria, including E coli.
  News Alerts, December 2018
• Alert EU Panel Recommends Tobramycin PARI for Pseudomonas in CF The European Medicines Agency's Committee for Medicinal Products for Human Use recommended Tobramycin PARI for Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis.
  International Approvals, December 2018
• Alert Higher Than Expected Contamination Rates Found With Duodenoscopes After Reprocessing, FDA Warns Findings from a 'human factors' study indicate that reprocessing instructions for duodenoscopes in current user manuals are hard for staff to follow.
  News Alerts, December 2018